Effects of a 2-week Relaxing Music Intervention on Anxiety, Stress, and Gut Symptoms in Aerobic Exercisers

NCT04671628 | Completed

• 1 other identifier: 1690558
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to determine the impacts of a 2-week relaxing music intervention on stress, anxiety, and gut symptoms in individuals who regularly perform structured aerobic exercise. Gut symptoms like bloating, reflux, cramping, nausea, etc. are relatively common during prolonged aerobic exercise. In addition, previous research has established that levels of anxiety and stress are associated with a higher occurrence of these gut symptoms. Relaxing music has reduced anxiety in certain populations, but currently, no studies are available on its effects on anxiety, stress, and gut symptoms in people who regularly do aerobic exercise.

Conditions

Gastrointestinal System--Abnormalities; Anxiety; Visceral Pain

Outcome Measures

Primary Outcomes (2)

• Change in gastrointestinal symptom severity

  The severity of several gastrointestinal symptoms will be assessed on a validated 0-10 scale.

  The intervention will last 2 weeks. Gastrointestinal symptoms will be collected for a 1-week period before the intervention and during the 2nd week of the intervention

• Change in anxiety levels

  Levels of anxiety will be assessed with the General Anxiety Disorder-7 questionnaire. Scores on the General Anxiety Disorder-7 range from 0 to 21, with higher scores indicating higher levels of anxiety.

  The intervention will last 2 weeks. The General Anxiety Disorder-7 will be assessed before the intervention begins and again after 2 weeks.

Secondary Outcomes (2)

• Change in visceral sensitivity

  The intervention will last 2 weeks. The Visceral Sensitivity Index will be assessed before the intervention begins and again after 2 weeks.

• Change in perceived stress

  The intervention will last 2 weeks. The Perceived Stress Scale 14 will be assessed before the intervention begins and again after 2 weeks.

Study Arms (2)

Relaxing music

EXPERIMENTAL

Behavioral: Relaxing music

Control

NO INTERVENTION

Interventions

Relaxing music BEHAVIORAL

Participants will be asked to listen to relaxing music for 30 minutes each day. They will allowed to choose between several playlists based on their preference.

Relaxing music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be at least 18 years of age
• do 120+ minutes per week of planned/structured aerobic exercise of at least moderate intensity
• have had at least mild anxiety over the past 2 weeks (GAD-7 score of 5 or more)
• not currently on a psychotropic medication, or if they are on one, they must have been on a stable dose for the past three months
• not currently listening to music for relaxation purposes regularly (\>60 minutes per week)
• have at least sometimes experienced gut symptoms (nausea, gas, bloating, cramping, side stitching, urge to defecate, etc.) during aerobic exercise sessions over the last month
• have access to the internet

You may not qualify if:

• not at least 18 years of age
• don't do 120+ minutes per week of planned/structured aerobic exercise of at least moderate intensity
• haven't had at least mild anxiety over the past 2 weeks (GAD-7 score of 5 or more)
• have recently started taking a psychotropic medication (within past 3 months)
• currently listening to music for relaxation purposes regularly (\>60 minutes per week)
• have never or rarely experienced gut symptoms (nausea, gas, bloating, cramping, side stitching, urge to defecate, etc.) during aerobic exercise sessions over the last month
• don't have internet access

Sponsors & Collaborators

• Old Dominion University: lead

Study Sites (1)

Human Performance Laboratory

Norfolk, Virginia, 23529, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Visceral Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Exercise Science

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 17, 2020
• Study Start: January 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

US (1)